Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults W… (NCT07074977) | Clinical Trial Compass
RecruitingPhase 2
Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO)
United States50 participantsStarted 2025-10-20
Plain-language summary
The primary objective of this study is to assess the PK/PD relationship of nemolizumab in adult participants aged 18 years or above with chronic pruritus of unknown origin (CPUO) during a 16-week treatment period.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant must be 18 years of age or older.
✓. Participants with chronic pruritus on normal-appearing skin (except for dry skin or excoriations) for at least 6 months before the screening visit.
✓. Chronic pruritus considered of unknown origin (i.e., without a clear association to another condition or medication) as assessed by the investigator at baseline.
✓. The pruritus must affect at least 4 of the following body areas: left lower limb, right lower limb, left upper limb, right upper limb, anterior trunk, posterior trunk.
✓. History of insufficient control of the chronic pruritus with prior treatment.
✓. Peak Pruritus Numeric Rating Scale (PP NRS) score greater than and equal to (\>=) 7 in the 24-hour period prior to the Screening visit.
✓. Weekly average Peak Pruritus Numeric Rating Scale (PP NRS) score \>= 7 in the week (7 days) immediately prior to randomization, as recorded in the patient diary.
✓. Female of childbearing potential must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study intervention injection.
Exclusion criteria
✕. Known dermatologic, systemic, neurologic or psychiatric condition(s), other than dry skin, that considered by the investigator to be the primary cause of current pruritus.
✕. Documented parasitic infection, including skin parasites such as scabies, within 12 weeks prior randomization.
What they're measuring
1
Population Pharmacokinetics (PopPK) Model of the Elimination of nemolizumab During the 16-week Treatment Period Point
Timeframe: From Baseline up to Week 16
2
Population Pharmacokinetics (PopPK) Model of the Distribution of nemolizumab During the 16-week Treatment Period Point
Timeframe: From Baseline up to Week 16
3
Population Pharmacokinetics (PopPK) Model of the Absorption of nemolizumab During the 16-week Treatment Period Point
Timeframe: From Baseline up to Week 16
4
Pharmacokinetic (PK)/Pharmacodynamic (PD) Model of the Effect of nemolizumab Systemic Exposure on Pruritus during 16-week Treatment Period
✕. Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.
✕. Diagnosis of chronic pruritus of neuropathic origin including but not limited to scalp dysesthesia, brachioradial pruritus, generalized neuropathic pruritus or chronic pruritus of psychogenic origin (pruritus associated with psychological disorders such as delusional parasitosis or Morgellons disease).
✕. Any medical or psychological condition or any clinically relevant laboratory abnormalities that put the participant at significant risk.
✕. History of bullous pemphigoid or positive bullous pemphigoid autoantibodies at screening.
✕. History of mastocytosis or serum total tryptase greater than (\>) 20 nanograms per milliliter (ng/ml) at screening.
✕. Active tuberculosis (TB) or non-tuberculosis mycobacterial infection, or a history of incompletely treated TB.